Overview:
Lumateperone is a novel second-generation atypical antipsychotic drug developed by Intracellular Therapies Incorporated (ITCI) and licensed by Bristol-Myers Squibb. It is indicated for treating schizophrenia and depressive episodes in bipolar I or bipolar II disorder.
It works through the interaction and modulation of dopaminergic, serotonergic, and N-methyl-D-aspartate (NMDA)-receptor-mediated glutamatergic neurotransmission. The exact mechanism is unknown, but the glutamatergic modulation property contributes to the antidepressant and antipsychotic effects of Lumateperone.
It was approved by the United States Food and Drug Administration (FDA) for the use of adult schizophrenia and bipolar depression in December 2019 and December 2021, respectively. Lumateperone is available as a capsule.
How Does Lumateperone Work?
Lumateperone acts as an antagonist of a few of the serotonin and dopamine receptors. Therefore, it modulates serotonin, dopamine, and glutamate neurotransmission. This is important because they are the neurotransmitters responsible for mental illnesses. The specific actions of Lumateperone include the following:
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Serotonin 5-HT2A receptor antagonist.
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Presynaptic partial agonist and postsynaptic antagonist of the dopamine D2 receptor.
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D1 receptor-dependent glutamate modulator.
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Serotonin reuptake inhibitor.
5-HT2A Receptor: 5-hydroxy-tryptamine or serotonin. This receptor is responsible for mediating physiological actions such as neuronal excitations, fear, and hallucinations. In addition, the receptor is necessary for the psychedelic actions of drugs like LSD. Overexpression of 5-HT2A can result in mental illnesses such as schizophrenia.
Dopamine D2 Receptor: Also known as D2R, this receptor is a protein encoded by the DRD2 gene. The actions of most antipsychotic drugs occur at this particular site. Disordered equilibrium of D2R states can lead to conditions like schizophrenia and autism.
Dopamine Receptor D1: Also known as DRD1, it is a protein encoded by the DRD1 gene. They are responsible to some extent for addiction and conditions like schizophrenia, obesity, substance abuse, and Tourette's syndrome.
What Are the Uses of Lumateperone?
What Are the Dosage Restrictions of Lumateperone?
Route of Administration: Oral.
Available Strengths: 42 mg capsule.
Dosage Form: Capsule with a blue cap and opaque white body imprinted with ‘ITI-007 42 mg.’
What Are the Special Considerations of Lumateperone?
1. Pregnancy: Exposure to Lumateperone in the third trimester of pregnancy may cause withdrawal and extrapyramidal symptoms in neonates.
2. Lactation: Data on the presence of Lumateperone in human milk or its effects on breastfed infants is unavailable. However, animal studies have indicated toxicity, and the possibility of extrapyramidal and withdrawal symptoms in human infants is not unlikely, as these side effects have occurred with other antipsychotics. Therefore, Lumateperone is contraindicated while lactating.
3. Hepatic Impairment: Patients with moderate to the severe hepatic impairment have displayed a higher exposure to Lumateperone. It is contraindicated in such patients, although dosage adjustment is not required in patients with mild hepatic impairment.
4. Individuals of Reproductive Potential: Animal studies have shown that Lumateperone may cause infertility.
5. Pediatric Population: Data on the safety and efficacy in pediatric patients is unavailable, but antidepressants have been known to cause suicidal behavior and thoughts. This is indicated in the boxed warning available with this drug, implying that the prescription of Lumateperone in pediatric patients should be done with caution and requires close monitoring.
6. Geriatric Population: The use of Lumateperone in patients over 65 years of age is unavailable for schizophrenic patients and insufficient for patients with bipolar depression to determine the difference in responses. It is contraindicated in patients with psychosis associated with dementia.
What Are the Contraindications of Lumateperone?
Lumateperone is contraindicated in patients who have previously experienced hypersensitivity to the administration of Lumateperone.
What Are the Warnings and Precautions of Lumateperone?
1. Geriatric Patients with Dementia-related Psychosis: Antipsychotics have been known to increase the mortality risks in geriatric patients with dementia-related psychosis. The most typical causes for this include the following mentioned below.
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Cardiovascular failure.
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Infectious diseases like pneumonia.
Lumateperone is therefore not recommended in such patients.
2. Younger Population: Suicidal thoughts and behaviors tend to be greater among children, adolescents, and young adults who are on antidepressants. Such patients need to be monitored for incidence of suicidal behaviors and clinical worsening of depression, particularly upon initial administration and when changing the dosage of drugs such as Lumateperone.
3. Neuroleptic Malignant Syndrome (NMS): Antipsychotic drugs may be associated with the development of neuroleptic malignant syndrome, characterized by the following signs. Suspected NMS should be managed with immediate cessation of Lumateperone, symptomatic treatment, and monitoring.
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Muscle rigidity.
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Hyperpyrexia or high-grade fever.
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Delirium.
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Autonomic instability or dysfunction may include dizziness and fainting spells on standing and exercise intolerance.
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Acute renal failure.
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Myoglobinuria can be understood as excessive myoglobin in the urine due to muscle breakdown that releases myoglobin in the blood. Myoglobin is a protein in the skeletal and heart muscles that supply oxygen to the muscle cells (myocytes).
4. Tardive Dyskinesia: Patients taking antipsychotic drugs may exhibit symptoms of tardive dyskinesia (involuntary, dyskinetic movements that can become irreversible). Patients on Lumateperone should preferably fulfill the following criteria:
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Respond well to antipsychotic drugs.
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They do not have alternative, equally effective treatment options available to them.
If tardive dyskinesia occurs upon administration of Lumateperone, drug discontinuation may be advisable.
5. Seizures: Multiple antipsychotic drugs, including Lumateperone, carry a risk of seizures, particularly in patients with a history of seizures.
6. Cognitive and Motor Impairment: Several antipsychotics, including Lumateperone, can cause drowsiness, leading to a diminished capacity for clear thinking, judgment, and motor skills. Lumateperone has demonstrated sedative effects in patients with schizophrenia and bipolar depression. Patients on Lumateperone should remain cautious about performing heavy machinery operations and driving tasks.
7. Orthostatic Hypotension: Orthostatic hypotension or low blood pressure when one stands up after sitting or lying down, and syncope, or the temporary loss of consciousness, may occur with antipsychotic drugs. This is especially possible in patients with cardiovascular disease, hypotension, and cerebrovascular disease history.
8. Falls: Lumateperone, like other antipsychotics, is capable of causing orthostatic hypotension and sedation, which can lead to falls and injuries. Therefore, fall risk assessments may be required in patients with conditions that can facilitate such falls if Lumateperone is concomitantly administered.
9. Metabolic Changes: Metabolic changes that typically occur with antipsychotics, including Lumateperone, include:
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Hyperglycemia or an increase in the blood sugar level, and diabetes mellitus. Evaluate fasting plasma glucose immediately before treatment, and continue to monitor it for the duration of the treatment.
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Increase in weight- Monitor weight when initiating treatment and for the entire duration of treatment.
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Dyslipidemia is an abnormal elevation of lipids- fats and cholesterol, in the blood. Evaluate the fasting lipid profile at baseline and continue to monitor throughout treatment.
10. Leukopenia, Neutropenia, and Agranulocytosis: Lumateperone and other antipsychotics have caused leukopenia- low leukocyte count and neutropenia- low neutrophil count in some patients. Agranulocytosis or severe, possibly fatal lowering of neutrophil count has occurred with the use of certain other antipsychotics. Leukocytes are the body’s white blood cells, whereas neutrophils are the body’s white blood cells with the specific function of fighting off bacteria and keeping infections at bay.
11.Cerebrovascular Reactions: Elderly patients with dementia-associated psychosis may display an increased vulnerability to strokes and transient ischemic attacks, temporary stroke-cardiac attacks. Lumateperone is not recommended for patients with dementia-related psychosis.
12. Body Temperature Regulation Issues: The regulation of the body's core temperature may be affected negatively by atypical antipsychotics such as Lumateperone. It should therefore be used with caution.
13. Dysphagia or Swallowing Difficulty: Antipsychotics including Lumateperone can cause aspiration and dysmotility of the esophagus, which is a difficulty while swallowing, spasmodic pain, and food regurgitation. These drugs should therefore be used with caution.
What Are the Drug Interactions of Lumateperone?
Drug interactions between Lumateperone and certain other drugs may adversely affect how Lumateperone acts on the body.
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Moderate to Strong CYP3A4 (Cytochrome P450 3A4) Inhibitors: Lumateperone exposure increases with moderate to potent CYP3A4 inhibitors, which may result in adverse reactions or side effects and thus must be avoided concomitantly.
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CYP3A4 Inducers: Lumateperone exposure decreases with using CYP3A4 inducers, which may impact drug efficacy. Avoid concomitant use of these drugs.
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Cytochrome P450 3A4 (CYP3A4): This is an enzyme found primarily in the liver and intestine. It is responsible for the oxidation of drugs and toxins in the body to facilitate removal from the body.
The drugs that fall under these categories are as follows.
For Patients:
What Is Schizophrenia?
Schizophrenia is a severe, chronic mental disorder where people’s interpretation of reality is distorted. Symptoms may include the following.
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Altered, odd patterns of thinking and behavior.
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Delusional thoughts.
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Hallucinations.
What Is Bipolar Disorder?
A condition characterized by extreme mood swings that run the gamut from emotional, manic highs to depressive lows.
What Is Bipolar Depression?
Depressive episodes in patients with bipolar disorder are referred to as bipolar depression.
Why Is Lumateperone Prescribed for Schizophrenia?
Lumateperone is prescribed for schizophrenia because it can simultaneously modulate the neurotransmission of the primary neuromodulators responsible for schizophrenia. These are serotonin, dopamine, and glutamate. The efficacy and safety of Lumateperone in treating schizophrenia have also proven to be favorable.
Why Is Lumateperone Prescribed for Bipolar Depression?
The neurotransmitter-modulation ability of Lumateperone makes it a good option for treating depression in patients with bipolar I and bipolar II disorders. In addition, it has shown promising efficacy, tolerability, and safety profile when prescribed either as monotherapy or as adjuvant therapy with lithium or valproate.
How Should You Take Lumateperone?
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Lumateperone can be taken in oral form. It is available in the form of a capsule of 42 mg.
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Ensure that you follow the instructions provided by the healthcare professional while taking Lumateperone.
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Lumateperone may be taken once daily with or without food.
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Do not consume Lumateperone for any purpose other than what was prescribed.
How Should You Store Lumateperone?
Lumateperone capsules should be stored at room temperature ranging from 68 to 77 degrees Fahrenheit or 20 to 25 degrees Celsius.
What Should You Discuss With Your Healthcare Provider Before Beginning Lumateperone Therapy?
Before beginning Lumateperone therapy, ensure that you give your healthcare provider a detailed medical history, family history of illnesses, and relevant personal history. These details should include the following.
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History of hypotension or low blood pressure.
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History of hypertension or high blood pressure.
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History of heart conditions.
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History of stroke.
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History of hyperglycemia or high blood sugar levels.
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Family history of hyperglycemia.
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History of diabetes mellitus or family history of diabetes mellitus.
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History of dyslipidemia or lipid imbalance.
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High total cholesterol levels, LDL (low-density lipoprotein) cholesterol, and triglycerides.
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Low levels of HDL (high-density lipoprotein) cholesterol.
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History of leukopenia (low white blood cell count).
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History of seizures.
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History of liver disorders.
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History of kidney diseases.
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Medications: Inform your healthcare provider of all the medicines, herbal supplements, and vitamins you may be taking as they may interact with Lumateperone in a counteractive manner, thereby canceling the effects of either or both drugs. There may also be severe drug reactions and side effects that your healthcare provider will be able to tell you about. They will also make changes to your drug regimen that will suit your medical needs.
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Pregnancy: Inform your healthcare provider if you suspect or have confirmed the pregnancy during treatment with Lumateperone, as it may harm your baby, particularly if taken during the third trimester of pregnancy.
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Lactation: Inform your healthcare provider if you are breastfeeding your infant, as the risks of Lumateperone passing into the breast milk are unknown, and it is, therefore, better to abstain from taking it when lactating.
What Are the Side Effects of Lumateperone?
The following side-effects may be experienced with Lumateperone.
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Sleepiness.
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Dizziness.
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Dry mouth.
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Nausea.
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Neuroleptic malignant syndrome.*
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Tardive dyskinesia.*
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Seizures.
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Cognitive and motor impairment.*
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Orthostatic hypotension.*
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Falls.
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Metabolic changes.*
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Leukopenia, neutropenia, and agranulocytosis.*
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Body temperature regulation issues.*
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Swallowing difficulty.
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Fertility issues in males and females.
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Increased mortality risks in elderly patients with dementia-associated psychosis.
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Increased risk of suicidal thoughts and behaviors in younger patients.
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Risks of cerebrovascular issues (like strokes) in elderly patients with dementia-related psychosis.
* see above
What Precautions Should You Take While on Lumateperone Therapy?
Lumateperone may cause drowsiness and general tiredness, as well as a propensity for dizziness and fainting. Make sure to exercise caution in the following areas mentioned below while on Lumateperone therapy.
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Avoid performing potentially dangerous tasks like operating heavy machinery or driving unless you have established that the sedative effect of Lumateperone does not affect you.
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Avoid extreme conditions of heat or dehydration.
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Stay hydrated. Try to drink lots of water.
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Avoid strenuous exercise.
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Try to remain in cooler, shaded areas that are out of direct exposure to the sun.
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Avoid wearing multiple layers of clothing or heavy clothing.
Can Lumateperone Be Abruptly Stopped?
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Do not attempt to change the dosage or completely stop taking Lumateperone without your healthcare provider’s say-so.
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If you experience any side effects or severe reactions, immediately inform your healthcare provider.
What To Do in Case of Overdose of Lumateperone?
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No antidote for Lumateperone overdose is currently in existence.
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In case of overdose, make sure you inform your healthcare provider immediately.
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Alternatively, you can contact your local poison control center or visit the emergency room.
For Healthcare Providers:
What Are the Indications of Lumateperone?
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Schizophrenia: Lumateperone may be prescribed for the treatment of schizophrenia in adults.
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Bipolar Depression:
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Monotherapy: Lumateperone may be used as monotherapy to treat episodes of depression in adult patients with bipolar disorder.
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Adjuvant Therapy: Lumateperone may be used as adjuvant therapy with lithium or valproate to treat depressive episodes in patients with bipolar disorder.
What Are the Components of Lumateperone?
Active Ingredient:
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Lumateperone (42 mg), present as Lumateperone tosylate salt.
Inactive Ingredients:
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Croscarmellose sodium.
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Gelatin.
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Magnesium stearate.
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Mannitol.
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Talc.
Colorants:
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Titanium dioxide.
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FD&C blue #1 and red #3.
What Is the Mechanism of Action of Lumateperone?
Lumateperone acts as a modulator for the neurotransmission of serotonin, dopamine, and glutamate. The efficacy hinges on the mediation of the following actions of Lumateperone.
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Serotonin 5-HT2A receptor antagonist.
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Presynaptic partial agonist and postsynaptic antagonist of the dopamine D2 receptor.
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D1 receptor-dependent glutamate modulator.
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Serotonin reuptake inhibitor.
What Are the Pharmacodynamics of Lumateperone?
Lumateperone Binding Affinity:
What Are the Pharmacokinetics of Lumateperone?
Oral administration of Lumateperone once daily shows the following.
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Steady State: Within five days.
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Increase in Steady-State Exposure: Dose-proportional or 21 mg to 56 mg.
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Coefficients of Variation: For Cmax (peak plasma concentration) and AUC (area under the concentration vs. time curve) were 68 % to 97 % at a steady state.
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Absorption:
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Absolute Bioavailability: 4.4%.
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Cmax: 1-2 hours after dosing.
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Food Effects: High-fat meals lower Lumateperone mean Cmax by 33 % and increase mean AUC by 9 %.
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Median Tmax: Delayed by 1 hour (1 hour at fasted state to 2 hours in the presence of food).
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Distribution:
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Protein Binding: 97.4% at five µM in human plasma.
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The volume of distribution after intravenous administration: 4.1 L/kg.
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Elimination:
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Lumateperone Clearance: Approximately 27.9 L/hour.
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Terminal Half-Life: 18 hours after intravenous administration.
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Metabolism: Enzymes involved in Lumateperone metabolization include:
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Uridine 5' diphosphate-glucuronosyltransferases (UDP-glucuronosyltransferase, UGT) 1A1, 1A4, and 2B15.
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Aldo Keto Reductase (AKR)1C1, 1B10, and 1C4.
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Cytochrome P450 (CYP) 3A4, 2C8, and 1A2.
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Excretion:
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Urine: 58 %.
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Feces: 29 %.
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Unchanged Lumateperone in urine was less than 1%.
What Are the Drug Interactions of Lumateperone?
Lumateperone does not inhibit the following:
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CYP1A2.
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CYP2C9.
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CYP2C19.
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CYP2D6.
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CYP3A4/5.
Lumateperone does not induce:
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CYP1A2.
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CYP2B6.
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CYP3A4.
Lumateperone minimally inhibits or does not inhibit:
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OCT2.
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OAT1.
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OAT3.
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OATP1B3.
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OATP1B1.
It is not a substrate of:
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P-GP.
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BCRP.
What Are the Clinical Trials of Lumateperone?
Schizophrenia:
A randomized controlled trial was conducted to evaluate the efficacy and safety of Lumateperone in patients with schizophrenia.
Study Design:
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Type of Study: Randomized, double-blinded, placebo-controlled clinical trial (Phase III).
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Duration of Study: 4 weeks.
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Methods: Patients (n=450) were randomized 1:1:1 into three groups:
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Lumateperone tosylate 42 mg OD (n=150.
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Lumateperone tosylate 28 mg OD (n=150).
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Placebo OD (n =150).
Outcome Measures:
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Primary Efficacy Endpoint: Mean change from baseline to day 28 on positive and negative syndrome scale (PANSS) total score versus placebo.
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Key Secondary Efficacy Endpoint: Clinical Global Impression–Severity of Illness (CGI-S) score.
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Other Secondary Efficacy Measures:
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PANSS positive, negative, and general psychopathology subscales.
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Personal and Social Performance (PSP) scale.
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PANSS-derived prosocial factors (P3, P6, N2, N4, N7, and G16).
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Calgary Depression Scale for Schizophrenia.
Results:
Modified intent-to-treat efficacy analysis (n = 435).
42 mg Lumateperone: Primary and key secondary efficacy objectives achieved.
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Primary Efficacy Objective (PANSS Total Score Improvement): Improvement v/s placebo from baseline to day 28 was statistically significant (least-squares mean difference [LSMD], −4.2; 95% CI, −7.8 to −0.6; P = .02; effect size [ES], −0.3).
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Secondary Efficacy Objective (CGI-S Score): Improvement v/s placebo from baseline to day 28 was statistically significant (LSMD, −0.3; 95% CI, −0.5 to −0.1; P = .003; ES, −0.4).
28 mg Lumateperone:
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Primary Efficacy Objective (PANSS Total Score Improvement): The LSMD from baseline to day 28 was not statistically significant [−2.6 (95% CI, −6.2 to 1.1; P = .16; ES, −0.2)
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Secondary Efficacy Objective (CGI-S Score): [−0.2 (95% CI, −0.5 to 0.0; P = .02; ES, −0.3).
Adverse Event Profile With Lumateperone:
Treatment-emergent adverse events were noted as follows.
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42 mg group: 64.7 %
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28 mg group: 56.7 %
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Placebo group: 50.3 %
The most anticipated adverse events that occurred included.
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Somnolence.
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Sedation.
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Fatigue.
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Constipation.
Severe adverse events included.
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Orthostatic hypotension.
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Convulsions.
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Asthma.
Bipolar Depression:
Monotherapy:
A randomized controlled study was conducted to evaluate the efficacy and safety of Lumateperone in patients with bipolar I or II disorder experiencing major depression.
Study Design:
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Type of Study: Randomized, double-blinded, placebo-controlled clinical trial (Phase III).
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Duration of Study: 6 weeks.
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Methods: Patients (n=381) were randomized 1:1 to two groups:
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Lumateperone 42 mg OD (n=188).
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Placebo OD (n =189).
Outcome Measures:
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Primary Efficacy Endpoint:Change from baseline to day 43 in score on the Montgomery-Åsberg Depression Rating Scale (MADRS).
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Key Secondary Efficacy Endpoint:Total score on the Clinical Global Impressions Scale-Bipolar Version severity scale (CGI-BP-S).
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Safety Assessments:
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Treatment-emergent adverse events.
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Laboratory parameters.
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Vital signs.
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Extrapyramidal symptoms.
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Suicidality.
Results:
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Primary Efficacy Objective (Day 43): Improvement from baseline to day 43 for the MADRS score was statistically significant in Lumateperone compared to placebo (LSMD compared with placebo, -4.6 points; effect size=-0.56). This applied to both bipolar I and II disorder patients.
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Secondary Efficacy Objective (Day 43): Improvement from baseline to day 43 for the CGI-BP-S total score was statistically significant in Lumateperone compared to placebo (LSMD compared with placebo, -0.9; effect size=-0.46).
Adverse Events Profile:
Treatment-Emergent Adverse Events:
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Somnolence.
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Nausea.
Extrapyramidal Symptoms: Low incidence and not significantly different from that of placebo. Other Minor Changes Observed:
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Vital signs.
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Weight.
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Metabolic assessments.
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Endocrine assessments.
Adjunctive Therapy:
A randomized controlled trial was conducted to evaluate the efficacy and safety of Lumateperone in patients with bipolar I or II disorder.
Study Design:
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Type of Study: Randomized, double-blinded, placebo-controlled clinical trial (Phase III).
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Duration of Study: 6 weeks.
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Methods: Patients (n=529) were randomized 1:1:1 to three groups, while on a maintenance dose of mood stabilizers (lithium or valproate):
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Lumateperone tosylate 42 mg OD (n = exact value unknown).
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Lumateperone tosylate 28 mg OD (n=exact value unknown).
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Placebo OD (n =exact value unknown).
Outcome Measures:
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Primary Efficacy Endpoint:Change from baseline to day 43 in score on the Montgomery-Åsberg Depression Rating Scale (MADRS).
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Key Secondary Efficacy Endpoint: Total score on the Clinical Global Impressions Scale-Bipolar Version severity scale (CGI-BP-S).
Results:
Lumateperone 42 mg:
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Primary Efficacy Objective: Lumateperone 42 mg: Least squares (LS) mean reduction from baseline versus placebo was 16.9 points versus 14.5 points (LSMD= 2.4 points; effect size = 0.27, p=0.0206).
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Secondary Efficacy Objective:Statistically significant improvement on the CGI-BP-S Depression Score for Lumateperone versus placebo (p=0.0082; effect size = 0.31).
Lumateperone 28 mg:
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Primary Efficacy Endpoint: Lumateperone 28 mg did not demonstrate statistically significant improvement versus placebo from baseline to Day 43. It did reveal a trend for dose-related improvement in depressive symptoms.
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Secondary Efficacy Endpoint (CGI-BP-S): Lumateperone 28 mg showed a statistically significant improvement versus placebo.
Adverse Events:
The safety profile was favorable. Everyday adverse events included the following:
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Somnolence (excessive sleepiness or drowsiness).
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Nausea.
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Dizziness.
Other adverse events that occurred were not significantly different from events that happened for those on placebo. These included the following mentioned below:
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Akathisia (movement disorder characterized by muscle quivering and restlessness)
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Extrapyramidal symptoms (stiff muscles, involuntary muscle contractions, involuntary facial movements, restlessness, and tremors).
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Restlessness.
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Weight changes.
Patient Counseling Information:
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Suicidal Thoughts and Behavior: Patients and caregivers must be aware of the potential for suicidal ideation to emerge. In case of suicidal tendencies, they must contact a healthcare provider immediately.
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Neuroleptic Malignant Syndrome: If patients or caregivers notice signs of NMS, they must report to their physicians or the emergency room immediately since it is potentially fatal.
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Metabolic Changes: Patients must be educated and trained on the need to monitor blood glucose, weight, and lipid levels. They must be taught to recognize relevant signs and symptoms that may indicate hyperglycemia and diabetes mellitus.
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Tardive Dyskinesia: If patients experience abnormal, jerky movements, they must report to the healthcare providers immediately.
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Orthostatic Hypotension and Syncope: Initiation and re-initiation of treatment may cause orthostatic hypotension and syncope. Patients must be made aware of this possibility.
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Cognitive and Motor Performance: Patients must be cautioned against performing dangerous activities until the effects of Lumateperone on their bodies have been deemed insignificant.
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Leukopenia and Neutropenia: Patients with pre-existing WBC disorders (low WBC) should be advised to check their CBC levels while on Lumateperone therapy.
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Heat Exposure and Dehydration: Patients must be cautioned against dehydration or overexposure to heat.
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Infertility: Patients of reproductive potential must be aware that Lumateperone can affect fertility.
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Pregnancy and Breastfeeding: Pregnant and lactating mothers should inform their healthcare providers of the same and cease taking Lumateperone if required.
- Medical History: Patients must give their physicians a thorough medical history, including all medicines, herbal supplements, and vitamins, to prevent drug interactions and adverse reactions.